Prospective study of 1308 nasopharyngeal swabs from 1033 patients using the LUMIPULSE SARS-CoV-2 antigen test: Comparison with RT-qPCR.
Prospective study of 1308 nasopharyngeal swabs from 1033 patients using the LUMIPULSE SARS-CoV-2 antigen test: Comparison with RT-qPCR.
复制标题
使用Lumipulse SARS-COV-2抗原测试：与RT-QPCR进行比较，对1033名患者的1308名鼻咽拭子进行了前瞻性研究。
DOI：
10.1016/j.ijid.2021.02.005
复制
发表时间：
2021-04
期刊：
影响因子：
--
通讯作者：
Omata M
中科院分区：
文献类型：
--
作者：
Hirotsu Y;Maejima M;Shibusawa M;Amemiya K;Nagakubo Y;Hosaka K;Sueki H;Hayakawa M;Mochizuki H;Tsutsui T;Kakizaki Y;Miyashita Y;Omata M
逆转录聚合酶链反应（RT-PCR）是检测严重急性呼吸综合征冠状病毒2型（SARS-CoV-2）的金标准。此前，使用回顾性收集的样本证明了LUMIPULSE SARS-CoV-2抗原定量检测的准确性。在本研究中，使用前瞻性样本对LUMIPULSE抗原检测进行了临床验证。总共从1033名个体中采集了1033份鼻咽拭子样本，并从43名随后检测出2019冠状病毒病（COVID-19）阳性的患者中采集了额外的275份随访样本。对所有1308份样本进行定量RT-PCR（RT-qPCR）和抗原检测。对结果不一致的患者进行抗体应答研究，以阐明是否发生血清转化。RT-qPCR鉴定出990份样本为阴性，43份为阳性，而抗原检测鉴定出992份样本为阴性，37份为阳性，4份为不确定。总体一致率为99.7%（1026/1029）。排除4个不确定结果后，抗原检测的敏感性、特异性、阳性预测值和阴性预测值分别为92.5%（37/40）、100%（989/989）、100%（37/37）和99.7%（989/992）。Kappa系数为0.960（95%置信区间为0.892-0.960），表明两种检验之间具有极好的一致性。在7名结果不一致的患者中，有5名血清阳性，这表明这种差异是由感染后期收集的样本引起的。使用随访样本，观察到抗原水平与病毒载量或循环阈值之间的相关性。这些检测结果之间的一致率在症状出现后0-9天收集的样品中趋于较高，但在此后收集的样品中逐渐降低。这项前瞻性研究表明，LUMIPULSE抗原检测是一种高度准确的SARS-CoV-2诊断检测。
Reverse transcription polymerase chain reaction (RT-PCR) is the gold standard for detection of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2). Previously, the accuracy of the quantitative LUMIPULSE SARS-CoV-2 antigen test was demonstrated using samples collected retrospectively. In this study, the LUMIPULSE antigen test was clinically validated using prospective samples. In total, 1033 nasopharyngeal swab samples were collected from 1033 individuals, and an additional 275 follow-up samples were collected from 43 patients who subsequently tested positive for coronavirus disease 2019 (COVID-19). All 1308 samples were subjected to quantitative RT-PCR (RT-qPCR) and the antigen test. The antibody response was investigated for patients with discordant results to clarify if seroconversion had occurred. RT-qPCR identified 990 samples as negative and 43 as positive, while the antigen test identified 992 samples as negative, 37 as positive and four as inconclusive. The overall concordance rate was 99.7% (1026/1029). Sensitivity, specificity, positive predictive value and negative predictive value of the antigen test were 92.5% (37/40), 100% (989/989), 100% (37/37) and 99.7% (989/992), respectively, after exclusion of the four inconclusive results. The kappa coefficient was 0.960 (95% confidence interval 0.892–0.960), suggesting excellent agreement between the two tests. Seropositivity in five of seven patients with discordant results suggested that the discrepancy was caused by samples collected during the late phase of infection. Using follow-up samples, correlation was observed between the antigen level and the viral load or cycle threshold value. The concordance rate between these test results tended to be high among samples collected 0–9 days after symptom onset, but this decreased gradually in samples collected thereafter. This prospective study demonstrated that the LUMIPULSE antigen test is a highly accurate diagnostic test for SARS-CoV-2.
登录
查看更多内容
SARS-COV-2病毒培养和亚基因组RNA，用于来自轻度冠状病毒疾病患者的呼吸标本。
影响因子：
11.8
作者：
Perera RAPM;Tso E;Tsang OTY;Tsang DNC;Fung K;Leung YWY;Chin AWH;Chu DKW;Cheng SMS;Poon LLM;Chuang VWM;Peiris M
通讯作者：
Peiris M
DOI：
10.1016/j.jmii.2020.12.009
发表时间：
2021-10
期刊：
Journal of microbiology, immunology, and infection = Wei mian yu gan ran za zhi
影响因子：
--
作者：
Omata M;Hirotsu Y;Sugiura H;Maejima M;Nagakubo Y;Amemiya K;Hayakawa M;Tsutsui T;Kakizaki Y;Mochizuki H;Miyashita Y
通讯作者：
Miyashita Y
影响因子：
3.1
作者：
Hirotsu, Yosuke;Mochizuki, Hitoshi;Omata, Masao
通讯作者：
Omata, Masao
影响因子：
11.8
作者：
Bullard, Jared;Dust, Kerry;Poliquin, Guillaume
通讯作者：
Poliquin, Guillaume
DOI：
10.1007/s10096-020-03913-9
发表时间：
2020-04-27
影响因子：
4.5
作者：
La Scola, Bernard;Le Bideau, Marion;Raoult, Didier
通讯作者：
Raoult, Didier